Reported Dec 13, 2023 · Ongoing
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Staar Surgical Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Staar Surgical Company · 1911 Walker Ave · Monrovia, CA · 91016-4846
Is this the product you have?
- EVO+VISIAN Implantable Collamer Lens
- REFVICM5_12.1. Phakic Intraocular lens
- Lot codes and dates
20 of 20 products
Products covered by this recall # Barcodes Product as published 1 00841542118965S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967 2 00841542118958S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863 3 00841542118910S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689 4 00841542118873S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624 5 00841542118927S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602 6 00841542118873S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625 7 00841542119030S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793 8 00841542118873S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627 9 00841542118873S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889 10 00841542118873S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554 11 00841542118972S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274 12 00841542118965S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126 13 00841542119030S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633 14 00841542118910S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475 15 00841542118873S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018 16 00841542118934S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365 17 00841542118965S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112 18 00841542118873S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884 19 00841542118910S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691 20 00841542118897S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278 - Amount recalled
- 20 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Their is a potential that intraocular implant devices may not meet specifications.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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